FDA.reportPublic FDA data

NDC 64616-045-01 - Earache Remedy

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64616-045
Requested NDC
64616-045-01
Package NDCs from labels
64616-045-01, 64616-045-02
Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ear Drops - Vitality Works, Inc.Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-045-01Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID1510
64616-045-02Earache Remedy1 in 1 CARTONLIQUID110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-045EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]9Current NDC, Legacy NDC, 2 package rows20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 86 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pest and Dustmite FormulaALLIUM CEPA, AMYL NITROSUM, ARSENICUM ALBUM, BLATTA AMERICANA, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HISTAMINUM HYDROCHLORICUM, HOUSE DUST MITE, HYALURONIDASE, INTERFERON (SUIS), IRIDIUM METALLICUM, KALI MURIATICUM, LAC CANINUM, MUCOSA NASALIS SUIS, SABADILLA, SELENIUM METALLICUM, SEROTONIN (HYDROCHLORIDE), WYETHIA HELENOIDESDeseret Biologicals, Inc.5a56ccec-5580-47da-a612-79aa9dc129482024-12-13WarningsExact identifier
unii: 660YQ98I10
Excelon Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.2e2883e2-dc0d-4b35-93be-514b85339c632024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing Wipes Clean Refreshing ScentBENZALKONIUM CHLORIDE WIPEGOJO Industries, Inc.4a8862cd-682f-4419-8f0c-794bae243e652024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing WipesBENZALKONIUM CHLORIDEGOJO Industries, Inc.70e0e729-4203-4258-97d3-2ad2eabf41e62024-12-12WarningsExact identifier
unii: F5UM2KM3W7
Epiforce PBAPTISIA TINCTORIA, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM IODATUM, CALCAREA CARBONICA, CLEMATIS ERECTA, GRAPHITES, KALI MURIATICUM, KALI SULPHURICUM, MEZEREUM PETROLEUM, SEPIABioActive Nutritional, Inc.d33282bf-2045-4b92-a377-013fa711c8772024-12-12WarningsExact identifier
unii: 660YQ98I10
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: U0NQ8555JD
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Dial refresh and renew Antibacterial Mountain FreshBENZALKONIUM CHLORIDEHenkel Corporationf9a347aa-808c-2095-e053-6394a90a58b12024-12-10WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial with VitaminsBENZALKONIUM CHLORIDEHenkel Corporationefd567c3-d75e-cf05-e053-2995a90af6912024-12-10WarningsExact identifier
unii: F5UM2KM3W7
Advanced Antibacterial Clean and SmoothBENZALKONIUM CHLORIDEEcolab Inc.881a94a1-68b8-4152-bdaa-e736812e889a2024-12-10WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial Kitchen Fresh HandsBENZALKONIUM CHLORIDEColgate-Palmolive Company65155ce6-5551-491b-a3df-e8ac2cc90ef12024-12-10WarningsExact identifier
unii: F5UM2KM3W7
DermaCen Non-Alcohol Foaming Hand SanitizerBENZALKONIUM CHLORIDECentral Solutions Incc7aa7ea9-7937-45bb-b32e-dd644dbf764e2024-12-09WarningsExact identifier
unii: F5UM2KM3W7
Quality Choice Ear Relief DropsMATRICARIA CHAMOMILLA WHOLE, MERCURIUS SOLUBILIS, SULFURChain Drug Marketing Association8a4b75d2-cec0-4ac3-94e3-208a01feace72024-12-09WarningsExact identifier
unii: G0R4UBI2ZZ
Family Wellness Ear Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURFamily Dollar Services Incdba89b5c-fe1d-485d-a1af-d8cd1f15b6152024-12-09WarningsExact identifier
unii: G0R4UBI2ZZ
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
unii: F5UM2KM3W7
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH CUCUMBER and TEA TREEBENZALKONIUM CHLORIDEUniversal Distribution Center LLC585ee68f-14fc-4b1f-b078-d31251bbc3f32024-12-06WarningsExact identifier
unii: F5UM2KM3W7
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH PEACH DREAMBENZALKONIUM CHLORIDEUniversal Distribution Center LLC7479686e-10f1-49e0-e053-2a91aa0ae8822024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH LAVENDER BOUQUETBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747a47d8-e5bc-1233-e053-2a91aa0a40932024-12-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.